Daxibotulinum toxin in isolated cervical dystonia

Currently available treatments for cervical dystonia call for an injection of botulinum toxin about 3 to 4 times a year. Is there a chance to achieve longer-lasting effects and to prolong injection intervals? A phase 2 trial with an investigational product, daxibotulinum toxin A for injection (RT002), revealed a clinically significant mean reduction of 38% from baseline in the TWSTRS total score and of 34% in the TWSTRS severity score at week 4 across all patients.

Dr Atul Patel (Kansas City Bone & Joint Clinic, USA) presented the results of the open-label, dose-escalating phase 2 study with a low (100-240 units) and a high-dose (300-450 units) daxibotulinum toxin A group in 37 patients with moderate-to-severe isolated cervical dystonia. Safety and preliminary efficacy of daxibotulinum toxin A as well as efficacy duration were assessed. The results demonstrated improvement in signs and symptoms. Clinically meaningful reductions in TWSTRS-severity, -disability, and -pain subscales were consistent and observed at all time points. At week 24, an average reduction in the TWSTRS total score of 30% and in the TWSTRS severity score of 20% was reported. Observed effects (median duration of effect defined as maintaining at least 30% of the treatment benefit attained in week 4) lasted for more than 24 weeks in both dose groups. Daxibotulinum toxin A for injection appeared to be generally safe and well-tolerated across all cohorts and dose groups through week 24 with no increase in treatment-emergent adverse events upon dose escalation. This also positively affected quality of life. Daxibotulinum toxin A may provide a long-lasting symptom reduction in cervical dystonia [1,2].

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   1. Patel AT, et al. Poster 205, TOXINS 2019, Copenhagen, Denmark, 16-19 January.
   2. Jankovic J, et al. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282.

Posted on 15 March 201918 March 2024